Associate Director, Downstream Process Development

Zymeworks-Inc; Bellevue (WA); Hybrid; USD 140,000 - 210,000; Full time

Benefits offered by this job

Industry leading vacation

Medical, dental and vision benefits

Employee Share Purchase Program

Paid time off to volunteer

Job summary

Zymeworks in Bellevue, WA, seeks an Associate Director for Downstream Process Development. Hybrid work with at least three days on-site. Lead downstream development, scale-up, and tech transfer across CMOs/CROs to support clinical programs.

The role requires a science/engineering degree and 8+ years in biopharmaceutical process development with strong regulatory and cross-functional skills. You will drive process characterization, CMC documentation, and collaboration with Quality, Regulatory,

Qualifications

• University degree in science or engineering required.
• Minimum 8 years of biopharmaceutical process development and GMP operations experience.
• Experience with contract manufacturing organizations (CMOs/CROs).
• Strong cross-functional collaboration and communication skills.
• Knowledge of cGMP and regulatory guidelines for biologics.

Responsibilities

• Serve as a strategic manager for downstream process development and production operations to drive program timelines.
• Direct strategic planning of downstream process development and manufacturing across clinical development phases.
• Collaborate with Research, Development, Clinical, Quality, Regulatory to define development strategies.
• Lead project-specific efforts in process development, scale-up, production and tech transfer between CMOs.
• Develop SOWs and oversee experiments at CMOs/CROs.
• Develop manufacturing processes for antibodies, multispecifics, and ADCs; escalate issues as needed.
• Design and support process characterization studies and control strategies for validation.
• Prepare technical CMC documentation and present to project teams.
• Work with R&D, Analytic Sciences, Technology and Quality to implement downstream operations.
• Ensure processes comply with quality requirements and regulatory guidelines.
• Serve as primary contact with CMOs and provide on-site technical support as needed.
• Provide technical support for all CMC activities, including investigations and change controls.
• Author and review CMC documents including protocols and batch records.

Skills

Cross-functional collaboration

Regulatory knowledge

Project management

Analytical reasoning

DoE methods

QbD

Education

University degree in science or engineering

Job description

Associate Director, Downstream Process Development

Company Description
Zymeworks is a global biotechnology company managing a portfolio of licensed healthcare assets and developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. The Company’s asset and royalty aggregation strategy focuses on optimizing positive future cash flows from an emerging portfolio of licensed products such as Ziihera® (zanidatamab-hrii) and other licensed products and product candidates such as pasritamig. In addition, Zymeworks is also building a portfolio of healthcare assets that can generate strong cash flows, while supporting the early-stage development of innovative medicines. We are a global company headquartered in Vancouver BC, with operations in Bellevue WA, Dublin IRE, and Singapore.

Why Work With Us

Nothing is more critical to our success than the quality of our team. The work we do is meaningful and impactful - we care about each other as well as the patients we serve. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

This role will be located in Bellevue and is hybrid with a minimum of 3 days per week onsite.

What You'll Do

• Serveas a strategic manager for the company’s downstream process development and production operationsto drive program timelines.
• Direct the strategic planning of downstream process development and manufacturing in support of all phases of clinical development including support of late clinical phase filings.
• Collaborate within cross-functional teams (Research, Development, Clinical, Quality, Regulatory), to define and execute development strategies for novel biotherapeutics and ADCs.
• Lead project-specific efforts in process development, scale-up, production and tech transfer of processes within and between CMOs.
• Participate in the development of RFP’s to solicit project specific bids from CMOs/CROs.
• Develop SOWs defining work to be performed and provide subsequent oversight of experiments and activities conducted at the CMO/CRO.
• Develop highly productive manufacturing processes in a timely manner for novel antibody, multispecific and ADC therapeutics. Brings issues to the attention of appropriate personnel as necessary.
• Design, manage and support process characterization studies and develops control strategies for process validation.
• Author technical documents and deliver presentations to technical and project groups.
• Contribute to the preparation and submission of CMC portions of regulatory submissions and updates (IND and BLA).
• Work directly with Research and Development, Analytic Sciences, and Technology and Quality teams to plan and implement execution of downstream process development and manufacturing operations.
• Ensure that all developed processes are compatible with quality requirements including regulations, policies, applicable guidelines and procedures.
• Serveas primary point of contact with contract manufacturing organizations (CMOs) andperformsperson-in-plant duties as needed to provide technical support for ongoing manufacturing.
• Providetechnical support for all CMC activities, including investigations, CAPAs, Change Controls, technology transfers, operation and lifecycle management of pre-clinical and cGMP manufacturing processes, ensuring all product delivery schedules are met.
• Authorand reviewtechnical CMC documentation, including protocols, technical reports, manufacturing batch records, SOPs, change controls and deviations.
• Drivetimely decisions andfacilitate active communication and information flow between CMOs andZymeworksteam members.
• Foster strong, long-lasting cross-functional working relationships with internal and external CMC, Quality Assurance, Project Management, Clinical Operations, and external manufacturing entities to ensure successful development and manufacture of all products.
• Promotea culture of continuous improvement in product quality and productivity.
• Workclosely with all internal and external resources to ensure DS supply availability.

What You'll Bring

• University degreein science or engineering and a minimum of 8 yearsrelated experience in biopharmaceutical process development and GMP operations or an equivalent combination of education and experience.
• Experience working with contract manufacturing organizations.
• Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships.
• Excellent organizational skills and the ability to work effectively in a high paced, fast changing environment.
• Consistent analytical reasoning ability.
• Familiarity with QbD and Control Strategy Development or multivariate analysis and DoE approaches to process development a plus.
• Strong background in the regulatory compliance requirements for the cGMP production of biologicals for clinical and commercial use.
• Working knowledge of regulatory guidelines and expertise in CMC, PK or toxicology for the advancement of therapeutics through different phases of development.
• Proficiency with cGMP and ICH guidelines.

Total Rewards

We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies.

The base salary range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the location for which the job is posted and does not include bonus, equity, or benefits. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate’s location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience).

Our total rewards package that includes:

• Industry leading vacation and paid time off
• Exceptional medical, dental and vision benefits by country
• Zymelife health and wellness benefits
• Employee Share Purchase Program
• Employee Equity Program
• Paid time off to volunteer in your community

This role is not eligible for relocation or immigration support.

All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability.

NOTE TO AGENCIES: Zymeworks values our relationships with our recruiting partners. We only accept resumes from those partners who have been contracted with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.